Quality Assurance Site Head / Director Quality Assurance
Location: San Diego
Posted on: October 13, 2019
Position Title: Quality Assurance Site Head/Director Quality
Location: San Diego, CA
DO WORK THAT MATTERS
At Abbott, diverse ideas, perspectives, and expertise allow us to
create the life-changing solutions that help people live healthier
lives. In 160 countries and with businesses spanning nutrition,
diagnostics, medical devices, and branded generic pharmaceuticals,
Abbott offers you enormous opportunities to explore your interests
and help you achieve your career and personal goals.
WHY IS THIS POSITION IMPORTANT?
We have an exciting opportunity for a Site Quality Head within our
Toxicology Manufacturing Site located in San Diego, CA. In this
role you will help shape the future of quality journey and create
something special within the broader Abbott network.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbotts
Diagnostics family of businesses, bringing together exceptional
teams of experts and industry leading technologies to support
diagnostic testing which provides important information for
treatment and management of diseases and other conditions.
* Acts as Quality Assurance Site Head, with overall responsibility
for ensuring product safety, reliability and quality.
* Leads a highly technical QA team Quality Specialists, Quality
Engineers and Analysts.
* Ensures that processes and staffing are appropriately developed
and implemented to maintain the quality system
* Sets strategic vision/goals in alignment with site organization
and division, ensure compliance within organization to all
applicable internal requirements and external regulations
* Establishes quality systems and plans to assure manufacturing of
the highest quality products to exceed customer requirements.
Interfaces with outside regulatory agencies as an Abbott
representative. Failure to adequately perform tasks can result in
non-compliance with governmental regulations
* Recruits, coaches and develops organizational talent. Fosters a
diverse workplace that enables all participants to contribute to
their full potential in pursuit of organizational objectives.
* Provides direction to managers, exempt specialists and non-exempt
support in various areas, groups and/or operations.
* Keeps the organization's vision and values at the forefront of
decision making and action.
* Demonstrates effective change leadership.
* Builds strategic partnerships to further departmental and
* Supports operations in continuous improvement initiatives by
providing direction on process validation/verification requirements
for proposed changes.
* Support New Product Initiatives as a Core Team Member supporting
design control and design transfer projects.
* Interacts internally and externally with executive level
management, outside regulatory agencies, customers, vendors and/or
* Coordinates across functional areas, business units, and/or
geographies in order to achieve company or area goals.
* Utilizes technical/professional knowledge and skills to
establish, interpret and execute company policies
* Monitors and ensures compliance with company policies and
procedures (e.g. compliance with FDA).
* Makes and executes operational decisions with a strategic
* Directs and controls the activities and budget of site QA
* Establish Quality Systems that are in compliance with regulatory
requirements and meet business needs.
* Reviews, analyzes and presents to senior staff and other groups
the effectiveness of the Quality System.
* Recommends and implements changes to the system as the result of
changing regulations and/or business needs.
* Analyzes data, makes decisions or provides recommendations to
senior staff regarding quality related crises (e.g. product
malfunction, field actions, production hold, customers
* Communicates quality policies, strategies and procedures to the
organization through written documents, presentations and
* Acts as Site Management Representative.
To be considered an applicant for this position you must show how
you meet the basic qualifications of the job in a resume or
document you upload, or by completing the work experience and
education application fields. Accepted file types are Microsoft
Word (DOC or DOCX), PDF, HTML, or TXT.
* Bachelors Degree in Life Sciences or Engineering
* 10 years of related work experience in Quality Assurance with at
least 5 years in a Quality Assurance site leadership role.
* Masters Degree or MBA
* IVD background preferred, Medical Devices/Pharma/Biotech
background is also acceptable
* Proven success track in
* Progressing department and site toward divisional and company
* Monitoring all costs associated with assigned organizational
* Monitoring industry trends and external environment in areas
relevant to the assigned organizational unit
* Being a subject matter expert and able to lead a team of
technical experts in CAPA, QMS, SOP, Design Control, Verification
* Developing and/or identifying new work processes that will have
broad applicability throughout the company
* Supporting new product development initiatives and successfully
supporting products from feasibility to design transfer and
* Conducting root cause analysis on highly technical problems and
solving problems that impact work processes and personnel in
multiple units or departments
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 103,000 colleagues
serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at
www.linkedin.com/company/abbott-/, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
AN EQUAL OPPORTUNITY EMPLOYER, ABBOTT WELCOMES AND ENCOURAGES
DIVERSITY IN OUR WORKFORCE.
We provide reasonable accommodation to qualified individuals with
disabilities. To request an accommodation, please send an email to
Keywords: Abbott, San Diego , Quality Assurance Site Head / Director Quality Assurance, Executive , San Diego, California
Didn't find what you're looking for? Search again!